Urinary incontinence, or the inability to control urination, is a major and debilitating problem affecting millions of people, especially women. The female""s natural support system for the urethra is a hammock-like supportive layer composed of endopelvic fascia, the anterior vaginal wall, and a distal attachment to the pubic bone. Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, weakening of the endopelvic fascia, and pubourethral prolapse of the anterior vaginal wall are some common characteristics of a patient with urinary incontinence.
Many procedures have been devised to treat urinary incontinence. Some have the goal of elevating the neck of the bladder to return it to a higher retropubic position. Many pubovaginal sling procedures have been developed to treat urinary incontinence. Some of these procedures involve positioning sling material under the urethra to provide elevation and support of the mid-urethra and/or the bladder neck. Examples of attachment sites for the sling include the anterior or superior portion of the pubis (e.g. with bone anchors and associated sutures), Cooper""s ligament, or rectus abdominus fascia. Examples of procedures for treating incontinence are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.
Slings used for pubovaginal procedures differ in the type of implantable material and anchoring methods. In some cases, the sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g. bone) through an abdominal and/or vaginal incision.
Complications associated with procedures for treating incontinence include urinary retention, bladder instability and erosion of an implanted article into surrounding tissue. See Spencer et al, A Comparison of Endoscopic Suspension of the Vesical Neck With Suprapubic Vesicourethropexy for Treatment of Stress Urinary Incontinence, J. Urol. 137: 411, (1987); Araki et al, The Loop Loosening Procedure for Urination Difficulties After Stamey Suspension of the Vesical Neck, J. Urol., 144; (1990); and Webster et al., Voiding Dysfunction Following Cystourethropexy: Its Evaluation and Management, J. Urol., 144 (1990).
With respect to sling procedures, if the sling mesh is too loosely associated with its intended physiological environment, the mesh may be ineffective in supporting the urethra and treating incontinence. Several complications can arise from a mesh that is too tightly placed including retention, sling erosion and other damage to surrounding tissue such as the urethra and vagina.
The TVT Tension-free Vaginal Tape procedure utilizes a knitted Prolene(trademark) nonabsorbable, polypropylene mesh. The mesh is a substantially flat, rectangular woven article. The mesh includes a plurality of holes that are sized to allow tissue ingrowth to help avoid infection. A removable plastic sheath surrounds the mesh and is used during insertion of the mesh. The sling is positioned near the urethra without the use of bone anchors. Once the sheath is removed from the mesh of the TVT product, friction between the mesh and tissue keeps the mesh in position and it becomes very difficult to subsequently adjust the position of the mesh relative to tissue. Attempts to move the sling once the sheath is removed may damage the sling or adjacent tissue such as the urethra or vagina. In addition to issues with initial placement of the sling, other tensioning related issues are experienced by users of the TVT product post operatively.
Proper tension of a sling during and after the surgical intervention are important factors for successful treatment of incontinence. Surgical approaches to applying tension or slack in a sling procedure vary widely. See Decter, Use of the Fascial Sling for Neurogenic Incontinence: Lessons Learned, The Journal of Urology, Vol. 150, 683-686 (1993).
Other prior art sling procedures use bone anchors or other methods of securing a sling. A difficulty that contributes to the unnatural positioning of the urethra is that some attachment sites, such as the rectus abdominus fascia or the top of the pubic bone, require very long sutures. Long sutures increase the difficulty in achieving the proper tension in the sutures and sling and increase the chances that intervening anatomical structures may interfere with proper tension. Improper sling tension or sling suture tension can result in increased lateral movement and momentum of the support structures or mesh sling when they are moved due to intra-abdominal pressures.
Because many slings are anchored at anatomical positions remote from the urethra, proper tension in a sling is a difficult objective to achieve. Results can vary widely.
U.S. Pat. No. 5,863,315 discloses a method of tensioning a suspended tissue mass. The method utilizes a suture tensioner comprising a handle, a main body and an annular recess.
More than a year prior to the filing date of the present application, Vesica Sling Kits were sold (by Boston Scientific, Microvasive, USA) in the United States that included a Suture Spacer. Surgeons were instructed to place the Suture Spacer on the top of the pubic tubercle (which is a location remote from the sling and remote from the urethra, vagina and bladder neck). The surgeon then places a suture about the Suture Spacer and ties a knot. As a knot is tied, the Suture Spacer is pulled downward onto the top of the pubic bone. Six or seven additional throws are tied and the Suture Spacer is withdrawn.
U.S. Pat. No. 5,474,518 discloses a device for correcting urinary incontinence by use of vesical suspension. The device includes a box that houses a drum with a toothed wheel that engages a worm gear.
U.S. Pat. Nos. 4,938,760 and 4,969,892 disclose a method of suspending the urethrovesical junction in females. An anchoring means for anchoring a suture in tissue is disclosed. The anchoring means comprises a rotating spool, a driving gear and an adjusting means.
PCT International Pub. No. WO 01/39670 discloses an implantable support sheet for providing suburethral stabilization for female patients. A clip is disclosed that inhibits folding of a central part of the sheet about its longitudinal axis.
U.S. Pat. No. 6,106,545 discloses a suture tensioning and fixation device for attachment of tendon to muscle or reattachment of ligaments to bone. The device includes a retaining element and suture thread engaging portions.
U.S. Pat. No. 6,117,067 discloses a device for the height-adjustable fixing and support of internal organs. The device includes a sling, threads, tube, small capsule and chamber. A needle is used to introduce or extract liquid.
PCT Inter. Pub. No. WO 00/74633 discloses tape for an incontinence procedure that incorporates a suture. The suture is used in combination with a one way suture retaining device as disclosed in U.S. Pat. No. 5,669,935.
U.S. Pat. No. 6,068,591 discloses an apparatus for treatment of female stress urinary incontinence with a support harness. The patent discloses an adjustable setting and Carter pin.
In one aspect, the present invention comprises an adjustable article that is particularly suitable for urological applications such as sling procedures. In preferred embodiments, the article can have features that afford adjustment of the tension of the article postoperatively or perioperatively, or both.
In one embodiment, the present invention comprises an elongate biocompatible material (e.g. synthetic or non-synthetic or combinations thereof) having first and second major surfaces, and first and second ends defining an overall longitudinal axial length therebetween, at least one fold (preferably two and more preferably four folds) about the longitudinal axis so as to reduce the overall axial length of the implantable article, and releasable holding means for retaining the fold in a folded position and, upon release, for affording unfolding of the fold to increase the overall axial length.
In another embodiment, at least one fold reduces the overall axial length more than at least one other fold. This implant optionally includes a feature for informing the surgeon of the identity of the particular fold that is being released. As a result, the surgeon may select to adjust the implant by a predetermined amount.
A number of different releasable holding means are contemplated such as a biocompatible releasable adhesive or a structured surface. Preferably, the releasable holding means includes a filament element. The filament may be sized to extend from the implantable article through a vaginal incision. Alternatively, the releasable holding means may be constructed to be palpable through vaginal tissue without requiring an incision through vaginal tissue.
In a preferred embodiment, the filament is associated with the biocompatible material by being threaded therethrough without additional structure for associating the filament with the biocompatible material. This embodiment avoids undesirable tissue interaction or reaction with structure for connecting the sling to the filament. The filament may be associated with the biocompatible material in a fashion that affords release by pulling on the filament. In a preferred embodiment, the filament is free of a permanent connection to the biocompatible sling.
The implantable article optionally includes identification means for distinguishing at least one filament element from another filament element. For example, the identification means may comprise constructing one filament of a different color than another filament.
In another embodiment, the width of a fold is less than the width of the biocompatible material. This embodiment is believed particularly suitable for use with a relatively thick biocompatible material. This embodiment helps avoid creating relatively thick structures capable of harboring microorganisms and potentially leading to infection or other adverse consequences. For example, the biocompatible material may comprise a plurality of discrete lengths of a flat polypropylene material with a plurality of holes, and the fold may be provided by a folded or S-shaped filament that connects discrete, unfolded portions of the polypropylene.
Other optional features are also disclosed. For example, the filament may include grasping means such as handles. The releasable holding means may include locating means capable of being detected through vaginal tissue, and selected elements (e.g. the filament, sling or fold) may include a radioopaque material as an aid in identifying its location.
In another aspect, the implantable article of the present invention comprises an elongate biocompatible material having first and second major surfaces, first and second ends defining an overall longitudinal axial length therebetween, a mid portion and first and second end portions. The article includes an adjustment filament element axially woven through the biocompatible material so as to alternatively project above one major surface and then another major surface along the first end portion. The adjustment filament is associated with the biocompatiable material to afford a reduction or an increase in the overall length of the implantable article. The implantable article is constructed and arranged such that the mid portion of the biocompatible material may be placed adjacent target anatomical tissue such as the urethra without any filament element situated between a major surface of the mid portion of the biocompatible material and the target anatomical tissue. In this embodiment, the sling material is free of structure that projects above a major surface of the sling adjacent the urethra. As a result, this embodiment avoids structure that could adversely interact or damage sensitive tissue such as the urethra.
This embodiment preferably includes a second adjustment filament element axially woven through the biocompatible material so as to alternatively project above one major surface and then another major surface along the second end portion. The second adjustment filament is associated with the biocompatiable material to afford a reduction or an increase in the overall length of the implantable article. The adjustment filament may be sized to extend from the biocompatible material through a vaginal incision. Alternatively, an end portion of the adjustment filament may be constructed to be palpable through vaginal tissue without requiring the end portion to extend through a vaginal incision. Other features such as grasping and locating means may also be included in this embodiment.
In another aspect, the implantable article of the present invention comprises a method of treating incontinence comprising the steps of (i) providing a sling comprising an elongate biocompatible material having first and second major surfaces, edges, and first and second ends defining an overall longitudinal axial length therebetween, at least one fold about the longitudinal axis so as to reduce the overall axial length of the sling, and releasable holding means for retaining the at least one fold in a folded position and, upon release, for affording unfolding of the at least one fold to increase the overall axial length, (ii) implanting the sling, and (iii) releasing the releasable holding means to reduce the tension of the sling. In one embodiment, the method includes the steps of creating a vaginal incision, providing a filament element as the releasable holding means, extending the filament element through the vaginal incision, and the step of releasing the releasable holding means to reduce the tension of the sling includes the step of pulling on the portion of the filament element that extends through the vaginal incision.
In another aspect, the present invention comprises a method of treating incontinence including the steps of: (i) providing a sling comprising an elongate biocompatible material having first and second major surfaces, first and second ends defining an overall longitudinal axial length therebetween, a mid portion and first and second end portions, (ii) weaving an adjustment filament through the biocompatible material along at least a portion of the longitudinal axial so as to alternatively project above one major surface and then another major surface along the first end portion such that the length of the biocompatible material may be adjusted, (iii) implanting the sling such that the mid portion of the biocompatible material is situated adjacent the urethra without any filament element situated between a major surface of the mid portion of the biocompatible material and the urethra, and (iv) changing the tension of the sling by manipulating the filament.
Preferably, the step of changing the tension of the sling by manipulating the filament includes the step of tying a knot in the filament element just adjacent the mid portion of the biocompatible material. For example, the step of tying a knot may includes the step of tying an adjustable knot or a non-adjustable knot or combinations thereof.